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OncoMatch/Clinical Trials/NCT05934513

A Study of GFH009 Monotherapy in Patients with Relapsed or Refractory Peripheral T-cell Lymphoma (PTCL)

Is NCT05934513 recruiting? Yes, currently enrolling (May 2026). This Phase 1/2 trial studies GFH009 for relapsed or refractory peripheral t-cell lymphoma (ptcl).

Phase 1/2RecruitingGenfleet Therapeutics (Shanghai) Inc.NCT05934513Data as of May 2026

Treatment: GFH009This is a multicentre, open-label phase Ib/II study. The purpose of the study is to assess the efficacy, safety/ tolerability and pharmacokinetic of GFH009 monotherapy in patients with relapsed or refractory peripheral T-cell lymphoma

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Extracted eligibility criteria

Cancer type

Non-Hodgkin Lymphoma

Performance status

ECOG 0–2(Ambulatory, capable of self-care)

Prior therapy

Max 5 prior lines
Min 2 prior lines

Cannot have received: chemotherapy

Exception: within 2 weeks prior to starting study drug

Patients who have received chemotherapy, radiotherapy or anti-tumor Chinese traditional medicines within 2 weeks prior to starting study drug

Cannot have received: radiotherapy

Exception: within 2 weeks prior to starting study drug

Patients who have received chemotherapy, radiotherapy or anti-tumor Chinese traditional medicines within 2 weeks prior to starting study drug

Cannot have received: anti-tumor Chinese traditional medicines

Exception: within 2 weeks prior to starting study drug

Patients who have received chemotherapy, radiotherapy or anti-tumor Chinese traditional medicines within 2 weeks prior to starting study drug

Cannot have received: targeted therapy

Exception: within 4 weeks or 5 half-lives whichever is shorter

received targeted therapy within 4 weeks or 5 half-lives whichever is shorter

Cannot have received: immunotherapy

received immunotherapy

Cannot have received: autologous hematopoietic cell transplant

Exception: within 90 days before screening

History of autologous HCT within 90 days before screening

Cannot have received: allogeneic stem cell transplant

Exception: within 90 days before screening

History of allogeneic stem cell transplant within 90 days before screening

Cannot have received: CDK9 inhibitor

History of previous exposure to any other CDK9 inhibitor

Lab requirements

Blood counts

Adequate haematologic function at screening

Kidney function

Adequate organ function at screening

Liver function

Adequate organ function at screening

Adequate haematologic and organ function at screening

Structured fields extracted by AI. May contain errors — verify against the official protocol.

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